Evidence map›Paper›PMID 39902332›Full record

ArticlePractical laboratory medicine2025

Impact of using cross-over CV and mean for two different lots of assay control on implementation of Westgard rules in chemical diagnostic tests.

Ayman Mohamed Nabil, Hayat Mirza Alsaif, Muneer Ahmad Aljamaan, Abdullah Abdullah H Algafly, Rashad Hassan Aleid, Raji Ali Helal, Zainab Ali Hussain Almutawah, Amani Abdulkareem S Alzayer, Walaa Ali Hussain Almutawah, Badr Abdullah Motlaq AlKhalaf

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Article in Practical laboratory medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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2 · The registry

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4 · The record

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5 · Who and what money

Authors and funding

10 authors.

Ayman Mohamed NabilMinistry of Health, Unnamed Road, النخيل, الرياض, 12382, Saudi Arabia.
Hayat Mirza AlsaifDammam Regional Laboratory, C3JM+73W, Ghirnatah, Dammam, 32245, Saudi Arabia.
Muneer Ahmad AljamaanDammam Regional Laboratory, C3JM+73W, Ghirnatah, Dammam, 32245, Saudi Arabia.
Abdullah Abdullah H AlgaflyAnak General Hospital, 7251 شارع القسمة،, Al Mahar، 3247, Anak, 32455&nbsp, Saudi Arabia.
Rashad Hassan AleidAnak General Hospital, 7251 شارع القسمة،, Al Mahar، 3247, Anak, 32455&nbsp, Saudi Arabia.
Raji Ali HelalBranch of the Ministry of Health in the Eastern Province, Saudi Arabia.
Zainab Ali Hussain AlmutawahEradah Hospital and Mental Health, King Abdul Aziz Rd, Jazan, Saudi Arabia.
Amani Abdulkareem S AlzayerEradah Hospital and Mental Health, King Abdul Aziz Rd, Jazan, Saudi Arabia.
Walaa Ali Hussain AlmutawahKing Faisal Hospital in Al-ahsa, Alfaisaliyah 1st, Al Hofuf, 36361, Saudi Arabia.
Badr Abdullah Motlaq AlKhalafMinistry of Health, Dammam, Eastern Region, Kingdom of Saudi Arabia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The main challenges of clinical laboratories concerning quality control include cost-effectiveness, variability in standardized materials, and evolving technologies across various diagnostic fields. While traditional QC practices and automation systems provide for accuracy, gaps exist, especially when applying Westgard rules to control lots for multiple assays. Such gaps result in inconsistent QC outcomes and unaddressed challenges in diagnostic reliability. Objective: This study aims to assess the effect of the cross-over coefficient of variation (CV) and mean values for different assay control lots on implementing Westgard rules to improve QC practices and enhance the accuracy and reliability of diagnostic tests in molecular laboratories. Methods: Data from 18 Levy-Jennings charts, with two assay control lots, were analyzed. Statistical comparisons of failure rates before and after setting the actual SD were performed using chi-square or T-tests at p < 0.05. Results: The analysis of 18 Levy-Jennings charts showed a significant reduction in failure rates after establishing actual mean and SD values compared to cross-over CV. Of the charts, 11 exhibited differences in failure occurrences, particularly rejection failures, highlighting improved QC reliability. Conclusion: These results emphasize the importance of accurate SD calculation in enhancing the effectiveness of Westgard rules. Therefore, establishing mean and SD values enhances QC reliability, reduces false failures, and ensures accurate Westgard rules application, while ongoing training in QC practices enhances diagnostic accuracy.

Indexed as

AccuracyCross-over coefficientDiagnostic test reliabilityQuality controlReagent lot variationWestgard rule

Identifiers

PMID39902332
PMCPMC11788727

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